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Effect of Mother DHA Supplementation on Term Newborn.

Effect of Maternal Supplementation With DHA During Pregnancy and Lactation on the Development of the Term Newborn

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01947426
Enrollment
120
Registered
2013-09-20
Start date
2008-04-30
Completion date
2011-04-30
Last updated
2013-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Development, Inflammation, Oxidative Stress

Keywords

DHA, term neonates, mother milk

Brief summary

In the present study, we evaluate the effect of the mother suplementación with DHA during the gestation and lactation on diverse aspects of the development of newborn. The effect on the oxidative stress, inflammatory signaling, bone turnover and piscomotor and visual development was studied. Women will in the sixth month of pregnancy, consume a diet balanced during last 3 months of pregnancy and the whole lactation. In addition the women will divide in two groups: one will receive a supplement of docosahexaenoic acid (DHA) to evaluate the effects on the development of the newborn child; whereas another group will receive a placebo. Different samples of blood of the mother and of mother milk will be taken and we will correlating her lipidic profile with the brain development of the newborn child, evaluated by different tests.

Detailed description

The sample will be 120 volunteers that will be enrolled in the services of Gynaecology of the infantile Hospital of Granada. The pregnant women will be assigned from random form to one of 2 groups that are described later: Group A: balanced diet Mediterranean, intake of 2 glasses / day of the dairy drink control. Group B: balanced Mediterranean diet together with the consumption of 400mg/day of DHA in the dairy product (2 glasses / day). The dairy products will be distributed in white packages without any indication that reflects the type of product that contains (double blind). Every volunteer will be assigned a key that guarantees the confidentiality of their analytical values. The dietary intervention will begin in the sixth month of pregnancy and will conclude to the third month of lactation (though there will improve itself the importance of a mother lactation up to 6 month postpartum). There will be obtained samples of blood (5 mL) of the mothers in the moment of the capture, in the childbirth and to 3 postpartum months. There will take a sample of blood of umbilical cord (5mL) in the moment of the childbirth (vein and artery). In addition there will take a sample of blood of the child (5mL) to 2.5 months. There will take also samples of mother milk (10mL), concretely of colostrum (2-3 postpartum days) and of mature(ripe) milk to 1, 2, 3 months. The samples will be preserved in freezer of-80ºC and sent to the different laboratories due preserved participants in order that there does not break the cold chain ( dry ice). In the first year of life of the child there will be practised tests of motive and cognitive development (Bayley's test and Fagan's test) in order to evaluate the influence of the dietetic intervention on the mother in the development of the child.

Interventions

DIETARY_SUPPLEMENTDHA Supplementation

mothers consuming 400 mg of DHA/day and their neonates

DIETARY_SUPPLEMENTControl (milk without DHA)

mothers consuming placebo product and their neonates

Sponsors

Puleva Biotech
CollaboratorINDUSTRY
Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Age
No minimum to 40 Years
Healthy volunteers
Yes

Inclusion criteria

1. Consent 2. mother with normal gestation.

Exclusion criteria

1. Risk factors during gestation. 2. Lactose intolerance 3. systemic illness. 4. Kwashiorkor. 5. Metabolic illness. 6. Foetal pathologies

Design outcomes

Primary

MeasureTime frameDescription
Change of Visual Development of newbornChange from Baseline at 12 months of lifeVisual Evoked Potentials

Secondary

MeasureTime frameDescription
Change of bone turnover biomarkers in blood samples during supplementationChange from Baseline after supplementation (2,5 months)indicators of Bone turnover in the mother and their child
Change of oxidative stress parameters in mother milk samples during supplementationChange from Baseline after supplementation (2,5 months)oxidative stress parameters (indicators of oxidative stress to lipids and proteins and antioxidant defense)
Motor and cognitive development of newborn12 monthsBayleys test

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026